scholarly journals A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study

2021 ◽  
pp. 1-10
Author(s):  
Kee D. Kim ◽  
K. Stuart Lee ◽  
Domagoj Coric ◽  
Jason J. Chang ◽  
James S. Harrop ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Conversion Rate ◽  
Neurological Recovery ◽  
Thoracic Spinal Cord ◽  
Intramedullary Spinal Cord ◽  
Cord Injury ◽  
Bioresorbable Polymer ◽  
Implantation Procedure

OBJECTIVEThe aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.METHODSThis was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.RESULTSNineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.CONCLUSIONSIn this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

scholarly journals Tissue bridges predict recovery after traumatic and ischemic thoracic spinal cord injury

Neurology ◽  
2019 ◽  
Vol 93 (16) ◽  
pp. e1550-e1560 ◽  
Author(s):  
Dario Pfyffer ◽  
Eveline Huber ◽  
Reto Sutter ◽  
Armin Curt ◽  
Patrick Freund
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Status ◽  
Lesion Length ◽  
Lesion Area ◽  
Thoracic Spinal Cord ◽  
Thoracic Spinal ◽  
Cord Injury ◽  
Cystic Cavity

ObjectiveTo investigate the spatiotemporal evolution and predictive properties of intramedullary damage and midsagittal tissue bridges at the epicenter of a thoracic spinal cord injury (SCI) using MRI.MethodsWe retrospectively assessed midsagittal T2-weighted scans from 25 patients with thoracic SCI (14 traumatic, 11 ischemic) at 1 month post-SCI. In 12 patients with SCI, linear mixed-effects models on serial MRI explored temporal trajectories of quantifiable lesion markers (area, length, and width) and tissue bridges. Using partial correlation analysis, we assessed associations between structural lesion characteristics at 1 month post-SCI and recovery at 1 year postinjury, adjusting for baseline clinical status, age, and sex.ResultsLesion area decreased by 5.68 mm2 (p = 0.005), lesion length by 2.14 mm (p = 0.004), and lesion width by 0.13 mm (p = 0.004) per month. Width of tissue bridges increased by 0.06 mm (p = 0.019) per month, being similar in traumatic and ischemic SCI (p = 0.576). Smaller lesion area, length, width, and wider tissue bridges at 1 month post-SCI predicted better recovery at 1-year follow-up.ConclusionsOver time, the immediate area of cord damage shrunk while the cystic cavity became demarcated. Adjacent to the cyst, midsagittal tissue bridges became visible. The width of tissue bridges at 1 month post-SCI predicted recovery at 1 year follow-up. Measures of lesion area and tissue bridges early after traumatic and ischemic thoracic SCI therefore allow characterizing the evolution of focal cord damage and are predictive of recovery in thoracic SCI. Thus, lesion extent and tissue bridges hold potential to improve diagnosis and patient stratification in interventional trials.

scholarly journals Characterization of neurological recovery following traumatic sensorimotor complete thoracic spinal cord injury

Spinal Cord ◽  
2010 ◽  
Vol 49 (3) ◽  
pp. 463-471 ◽  
Author(s):  
J Zariffa ◽  
J L K Kramer ◽  
J W Fawcett ◽  
D P Lammertse ◽  
A R Blight ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Neurological Recovery ◽  
Thoracic Spinal Cord ◽  
Thoracic Spinal ◽  
Cord Injury

Impact of Early (<24 h) Surgical Decompression on Neurological Recovery in Thoracic Spinal Cord Injury: A Meta-Analysis

2019 ◽  
Vol 36 (18) ◽  
pp. 2609-2617 ◽  
Author(s):  
Paula Valerie ter Wengel ◽  
Enrico Martin ◽  
Philip Charles De Witt Hamer ◽  
Ricardo E. Feller ◽  
Julie Anne E. van Oortmerssen ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Meta Analysis ◽  
Surgical Decompression ◽  
Neurological Recovery ◽  
Thoracic Spinal Cord ◽  
Thoracic Spinal ◽  
Cord Injury

scholarly journals Neuro-Spinal Scaffold"! Implantation in Patients with Acute Traumatic Thoracic Complete Spinal Cord Injury: 24 Month Results From the INSPIRE Study

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Kee D Kim ◽  
K Stuart Lee ◽  
Jason J Chang ◽  
Richard M Toselli
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Natural History ◽  
Primary Endpoint ◽  
Conversion Rate ◽  
Clinical Investigation ◽  
Open Label ◽  
Cord Injury ◽  
Complete Spinal Cord Injury

Abstract INTRODUCTION The Neuro-Spinal Scaffold"! (NSS) is an investigational biodegradable device developed to facilitate spinal cord repair following intraparenchymal implantation within the injured spinal cord. An open-label, single-arm, multicenter clinical study was conducted to evaluate the safety and efficacy of the device in acute thoracic complete spinal cord injury (SCI). Here, we report on available 24-mo follow-up data. METHODS The INSPIRE Study (NCT02138110) enrolled patients with nonpenetrating, thoracic (T2-T12/L1) AIS A SCI within 96 h of injury. Safety and neurological outcomes were assessed. The primary endpoint was AIS conversion rate at 6 mo. The study included an Objective Performance Criterion (OPC) defined as at least 25% of patients demonstrating an AIS grade improvement at 6 mo, which was derived from a 16% natural history AIS conversion rate in the studied patient population.[1] RESULTS A total of 19 patients were implanted with the NSS. There were 3 deaths determined by investigators to be unrelated to the NSS or its implantation. A total of 8 patients have completed the 24-mo assessment visit, with additional follow-up ongoing. Seven of the sixteen patients who reached the 6-mo primary endpoint visit experienced an AIS grade improvement (43.8%; AIS B, n = 5; AIS C, n = 2). Three of the five patients who converted to AIS B experienced further improvement to AIS C at 12 (n = 2) and 24 mo (n = 1) postinjury. At last follow-up, none of the patients with AIS conversion had deteriorated and there were no unanticipated or serious adverse device effects related to the NSS or its implantation as determined by investigators. CONCLUSION The INSPIRE study is the first to clinically evaluate implantation of a scaffold as a treatment for acute SCI. This study describes the safety of the NSS and feasibility of implantation. The AIS conversion rate exceeds published natural history rates and the OPC. Available results at twenty-four months continue to support further clinical investigation.

Neurological recovery following traumatic spinal cord injury: a systematic review and meta-analysis

2019 ◽  
Vol 30 (5) ◽  
pp. 683-699 ◽  
Author(s):  
MirHojjat Khorasanizadeh ◽  
Mahmoud Yousefifard ◽  
Mahsa Eskian ◽  
Yi Lu ◽  
Maryam Chalangari ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Recovery Rate ◽  
Meta Analysis ◽  
Neurological Recovery ◽  
Traumatic Spinal Cord Injury ◽  
Mechanism Of Injury ◽  
Cord Injury ◽  
Lower Recovery

OBJECTIVEPredicting neurological recovery following traumatic spinal cord injury (TSCI) is a complex task considering the heterogeneous nature of injury and the inconsistency of individual studies. This study aims to summarize the current evidence on neurological recovery following TSCI by use of a meta-analytical approach, and to identify injury, treatment, and study variables with prognostic significance.METHODSA literature search in MEDLINE and EMBASE was performed, and studies reporting follow-up changes in American Spinal Injury Association (ASIA) Impairment Scale (AIS) or Frankel or ASIA motor score (AMS) scales were included in the meta-analysis. The proportion of patients with at least 1 grade of AIS/Frankel improvement, and point changes in AMS were calculated using random pooled effect analysis. The potential effect of severity, level and mechanism of injury, type of treatment, time and country of study, and follow-up duration were evaluated using meta-regression analysis.RESULTSA total of 114 studies were included, reporting AIS/Frankel changes in 19,913 patients and AMS changes in 6920 patients. Overall, the quality of evidence was poor. The AIS/Frankel conversion rate was 19.3% (95% CI 16.2–22.6) for patients with grade A, 73.8% (95% CI 69.0–78.4) for those with grade B, 87.3% (95% CI 77.9–94.8) for those with grade C, and 46.5% (95% CI 38.2–54.9) for those with grade D. Neurological recovery was significantly different between all grades of SCI severity in the following order: C > B > D > A. Level of injury was a significant predictor of recovery; recovery rates followed this pattern: lumbar > cervical and thoracolumbar > thoracic. Thoracic SCI and penetrating SCI were significantly more likely to result in complete injury. Penetrating TSCI had a significantly lower recovery rate compared to blunt injury (OR 0.76, 95% CI 0.62–0.92; p = 0.006). Recovery rate was positively correlated with longer follow-up duration (p = 0.001). Studies with follow-up durations of approximately 6 months or less reported significantly lower recovery rates for incomplete SCI compared to studies with long-term (3–5 years) follow-ups.CONCLUSIONSThe authors’ meta-analysis provides an overall quantitative description of neurological outcomes associated with TSCI. Moreover, they demonstrated how neurological recovery after TSCI is significantly dependent on injury factors (i.e., severity, level, and mechanism of injury), but is not associated with type of treatment or country of origin. Based on these results, a minimum follow-up of 12 months is recommended for TSCI studies that include patients with neurologically incomplete injury.

First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury

Neurosurgery ◽  
2016 ◽  
Vol 79 (2) ◽  
pp. E305-E312 ◽  
Author(s):  
Nicholas Theodore ◽  
Randall Hlubek ◽  
Jill Danielson ◽  
Kristin Neff ◽  
Lou Vaickus ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Supplemental Digital Content ◽  
Digital Content ◽  
Traumatic Spinal Cord Injury ◽  
Polymer Scaffold ◽  
Cord Injury ◽  
Bioresorbable Polymer ◽  
Human Implantation

Abstract SUPPLEMENTAL DIGITAL CONTENT Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.neurosurgery-online.com). BACKGROUND AND IMPORTANCE: A porous bioresorbable polymer scaffold has previously been tested in preclinical animal models of spinal cord contusion injury to promote appositional healing, spare white matter, decrease posttraumatic cysts, and normalize intraparenchymal tissue pressure. This is the first report of its human implantation in a spinal cord injury patient during a pilot study testing the safety and feasibility of this technique (ClinicalTrials.gov Identifier: NCT02138110). CLINICAL PRESENTATION: A 25-year-old man had a T11-12 fracture dislocation sustained in a motocross accident that resulted in a T11 American Spinal Injury Association Impairment Scale (AIS) grade A traumatic spinal cord injury. He was treated with acute surgical decompression and spinal fixation with fusion, and enrolled in the spinal scaffold study. A 2 × 10 mm bioresorbable scaffold was placed in the spinal cord parenchyma at T12. The scaffold was implanted directly into the traumatic cavity within the spinal cord through a dorsal root entry zone myelotomy at the caudal extent of the contused area. By 3 months, his neurological examination improved to an L1 AIS grade C incomplete injury. At 6-month postoperative follow-up, there were no procedural complications or apparent safety issues related to the scaffold implantation. CONCLUSION: Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold.

Long-Term Follow-Up After Spinal Cord Injury in Canada

2006 ◽  
Author(s):  
Mark I. Tonack ◽  
Sander L. Hitzig ◽  
B. Catharine Craven ◽  
Kent A. Campbell ◽  
Kathryn A. Boschen ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cord Injury ◽  
Long Term Follow Up

OPEN HAEMORRHOIDS SURGERY IN SPINAL CORD INJURY PATIENTS

2020 ◽  
Vol 4 (11) ◽  
Author(s):  
Khaled Hassan
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Anal Fissure ◽  
Open Surgery ◽  
Anal Fissures ◽  
Cord Injury ◽  
Long Term Follow Up ◽  
Grade Iii

This Pilot retrospective research conducted on the results of open surgery in patients with Grade III and IV haemorrhoids With SCI. No major complications had arisen at 6 weeks post-operative and all wounds had healed, but 1 patient Anal fissure recurrence. 75% of patients reported a substantial increase in anorectal anorexia during long-term follow-up. With symptoms. Five patients reported recurrences: three haemorrhoids (18 percent) and two anal fissures (25 percent).   Keywords: Haemorrhoids, Pilot retrospective research, Anorectal Anorexia.

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